Effects of Pentazocine Versus Lorazepam on Manic Symptoms

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00431184
First received: February 1, 2007
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals. To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases manic symptoms.


Condition Intervention Phase
Bipolar Disorder
Schizoaffective Disorder
Manic Disorder
Mania
Manic State
Drug: Pentazocine
Drug: Lorazepam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pentazocine Versus Lorazepam on Manic Symptoms

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Mania Acute Rating Scale (MACS) [ Time Frame: On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention ] [ Designated as safety issue: No ]
    Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity. The change in MACS scores from baseline and those following treatment administration were averaged. The number below represents the average mean change.


Secondary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: at the time of administration of intervention and 5 hours following administration of intervention ] [ Designated as safety issue: No ]
    The YMRS is used to assess manic symptoms. There are 11 questions which ask the patient to rate the severity of symptoms. Scores range from 0 to a maximum of 60. All questions are rated based on severity, with a higher score signifying increased severity. Questions 1-4, 7, and 10 are rated on a 0-4 scale. Questions 5, 6, 8, and 9 are rated on a 0-8 scale.


Enrollment: 19
Study Start Date: January 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pentazocine then Lorazepam
In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
Drug: Pentazocine
see arms description
Other Name: Talwin Nx
Drug: Lorazepam
see arms description
Other Name: Ativan
Active Comparator: Lorazepam then Pentazocine
In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
Drug: Pentazocine
see arms description
Other Name: Talwin Nx
Drug: Lorazepam
see arms description
Other Name: Ativan

Detailed Description:

Dysregulation of the opioid system may underlie the pathophysiology of mood disorders, such as bipolar disorder. Drugs that modulate the opioid system might be effective treatments for bipolar disorder. The profile and actions of the kappa-opioid system make drugs that target this system particularly promising as a treatment modality, with relatively low risk of addictive properties. Pentazocine is an approved drug for pain relief with a good side effect profile. It is predominantly a kappa opioid agonist with weaker side effects at mu opioid receptors, at which it is an antagonist. Data from our open-label pilot study of pentazocine had promising results. We will follow up on these findings with a double-blind, active-control study of individuals with bipolar disorder or schizoaffective disorder who are currently hospitalized with acute mania. The antimanic effects of pentazocine will be compared with an active control (ativan).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bipolar or schizoaffective disorder
  • currently manic
  • no acute medical issues
  • no substance withdrawal

Exclusion Criteria:

  • unable to give informed consent
  • using opiates for pain management
  • history of head injury, dementia, or mental retardation
  • seizure disorder
  • glaucoma
  • unstable cardiac condition or arrhythmia
  • moderate-severe pulmonary disease
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431184

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Stanley Medical Research Institute
Investigators
Principal Investigator: Beth L Murphy, MD/PhD Mclean Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00431184     History of Changes
Other Study ID Numbers: 2006-P-002344
Study First Received: February 1, 2007
Results First Received: June 19, 2014
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
bipolar disorder
bipolar mania
schizoaffective disorder
schizoaffective mania
mania
kappa opiates
opiates

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Lorazepam
Pentazocine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on August 28, 2014